MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-24 for SWANSON HUNTER ROD SIZER SET SEE H10 manufactured by Wright Medical Technology, Inc..
[106265038]
The part number of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device. However, the suspect devices in use are part # 24370003, 24370004, 24370005 and # 24370006. Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[106265039]
Allegedly, the surgeon inserted a tendon spacer sizer trial in the patient by mistake. (the sizer had been sterilized. ) comments from surgeon: the sizer will be removed in a few months so till then, the surgeon would like to leave it in the patient unless it is necessary to remove it immediately. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2018-00030 |
| MDR Report Key | 7453749 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-24 |
| Date of Report | 2018-03-26 |
| Date of Event | 2018-03-15 |
| Date Facility Aware | 2018-03-15 |
| Date Mfgr Received | 2018-07-04 |
| Date Added to Maude | 2018-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1023 CHERRY ROAD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer Phone | 9014516318 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWANSON HUNTER ROD SIZER SET |
| Generic Name | PROSTHESIS, TENDON, PASSIVE |
| Product Code | HXA |
| Date Received | 2018-04-24 |
| Model Number | SEE H10 |
| Lot Number | NI |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-24 |